The following data is part of a premarket notification filed by Syneron Beauty with the FDA for Tanda Mini Skincare System.
| Device ID | K124042 |
| 510k Number | K124042 |
| Device Name: | TANDA MINI SKINCARE SYSTEM |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | SYNERON BEAUTY 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SYNERON BEAUTY 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-04-02 |
| Summary: | summary |